Atlas FDA

KOZ

22 FDA 510(k) clearances · Product code

89 daysmedian time to decision
210 days90th percentile
22clearances measured

FDA profile

Official device name
Beads, Hydrophilic, For Wound Exudate Absorption
Device class
Class I (low risk)
Regulation
21 CFR 878.4018
Medical specialty
General, Plastic Surgery
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
INCARE PINSITE DRESSING (K905206)Hollister, Inc.1991-04-12
CUTINOVA HYDRO (K905688)Beiersdorf, Inc.1991-04-01
IODOSORB GEL (K905069)Perstorp AB C/O Robert Joel Slomoff1991-01-31
REDI-RELEASE ABSORBENT DRESSING (K904604)Fountain Pharmaceuticals, Inc.1991-01-07
BIOCLUSIVE(R) ABSORBENT DRESSING (K896828)Johnson & Johnson International1990-11-21
DERMASORB WOUND CONTACT LAYER DRESSING (K903645)Convatec, A Division of E.R. Squibb & Sons1990-11-21
ALLEVYN DRESSING CLAIMS CHANGE (K904412)Smith & Nephew United, Inc.1990-10-23
INTRASITE CAVITY WOUND DRESSING (LABEL REVISION) (K901876)Smith & Nephew United, Inc.1990-06-28
EXUSORB(TM) DRY/WET DRESSING (K896176)Controlled Therapeutics Corp.1989-11-24
INTRASITE CAVITY WOUND DRESSING (K895354)Smith & Nephew United, Inc.1989-11-07
ENVISAN PAD (K874552)Marion Laboratories, Inc.1988-01-22
DEBRISAN ABSORBENT PAD (K872453)Pharmacia, Inc.1988-01-14
ENVISAN PASTE (K874553)Marion Laboratories, Inc.1987-12-18
DEXTRANOMER (K872117)Interworld, Inc.1987-07-24
PHARMASEAL WOUND CARE DRESSING PAD (K870941)American Pharmaseal Div. Ahsc1987-03-27
IODOSORB POWDER (K870559)Perstorp AB C/O Robert Joel Slomoff1987-03-20
BIPORE O.2 MICRON HYDROPHOBIC FILTER ASSEMBLY (K844625)Bipore, Inc.1985-01-16
COMFEEL POWDER (K834343)Coloplast A/S1984-11-08
HOLLISTER WOUND EXUDATE ABSORBER (K820160)Hollister, Inc.1982-04-21
DEBRISAN (DEXTRANOMER) PASTE (K800737)Pharmaseal Laboratories1980-08-04
MEDICAL PROTEIN HYDROLYSATE REVITAL (K780775)Robertson Resources, Inc.1978-11-30
CLEANSING AGENT, NEW WOUND (DEBRISSU) (K760469)Pharmaseal Laboratories1976-12-16

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Every clearance here is in the API, with alerts when new ones post.